# K962592: Ophthalas 532 Solid State Photocoagulator, or Equivalent Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories
- Decided: Sep 23, 1996 after 83 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
43 later devices descend from it; 4 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ophthalas® 532 Photocoagulator: named in the summary without a submission number
- (no number) blue-green Argon Ophthalmic Lasers: named in the summary without a submission number

## Most influential descendants
- K031665: Iris Medical Oculight GL/GLX Laser Systems (2003), 21 descendants of its own
- K062624: Next Generation Laser (2007), 18 descendants of its own
- K980547: Nidek Prima Model Gyc-1500/2000 (1998), 18 descendants of its own
- K101285: Constellation Vision System (2010), 17 descendants of its own
- K032085: Green Laser Photocoagulator Model Gyc-1000 (2003), 17 descendants of its own

## Indications for use
The Ophthalas 532 laser is intended to be used in all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation; Transcleral Cyclophotocoagulation; Internal Sclerostomy; Iridotomy; and Trabeculoplasty.

Source page: https://510kreport.com/device/K962592
Methodology: https://510kreport.com/methodology